(252 days)
ABLATE-IQ™ assists physicians in identifying ablation targets, assessing proper ablation probe placement and visualizing treatment zones when used with the NEUWAVE Microwave Ablation System (NEUWAVE System). The software is not intended for diagnosis, to predict ablation volume, or to predict ablation success.
ABLATE-IQ™ formally known as Ablation Confirmation, is a Computed Tomography (CT) image processing software package available as an optional feature for use with the NEUWAVE System. ABLATE-IQ™ is resident on the NEUWAVE Microwave Ablation System and is accessible to the physicians via a second, dedicated monitor with its own user interface separate from the ablation user interface. ABLATE-IO™ functions are controlled via a USB connected mouse. ABLATE-IQ™ connects to a facility PACS system and CT scanner and receives and sends CT, fused PET and MR images via the DICOM protocol over the hospital network. DICOM enables the integration of scanners, servers, workstations, printers, and network hardware from multiple manufacturers into an electronic PACS.
ABLATE-IQTM contains a wide range of image processing tools, including:
- · 2D image manipulation
- · 3D image generation (from 2D images)
- · 3D image manipulation
- · Region of interest (ROI)/target identification, segmentation, and measurement
- · Image-based detection of ablation probes manually placed by the user (physician)
- · Registration of multiple images into a single view
The provided text is a 510(k) Summary for the ABLATE-IQ™ device, formerly known as Ablation Confirmation. It outlines the device's description, modifications, comparison to a predicate device, and the summary of non-clinical and/or clinical tests.
However, the document focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and detailed study results as one might find in a full clinical or performance study report. Therefore, I can extract information related to the device's testing and general claims of performance, but specific quantitative acceptance criteria and detailed study parameters (like sample size for test sets, number of experts, adjudication methods, MRMC studies, or training set details) are not explicitly provided in this 510(k) summary.
Here's the information that can be extracted and a clear indication of what is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states, "The ABLATE-IQ™ software passed all pre-determined acceptance criteria identified in the test plan." However, the specific pre-determined acceptance criteria and quantitative reported device performance are not listed. The document mentions general validation of software functions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided. The document refers to "an established test plan" and "Design verification documents" but does not specify the number of cases or images used in the test set.
- Data Provenance: Not provided. There is no information about the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not provided.
- Qualifications of Experts: Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: Not indicated. The document states the software "assists physicians," suggesting a human-in-the-loop scenario, but it does not describe an MRMC study comparing human readers with and without AI assistance, nor does it provide an effect size.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not explicitly detailed. The text mentions "ABLATE-IQ™ was tested in accordance with an established test plan that fully evaluated all functions performed by the software." This would imply standalone testing of the algorithm's functions (e.g., probe identification, ROI segmentation, image manipulation), but specific performance metrics for these standalone functions are not presented. The device is described as assisting physicians, implying it's not purely standalone in clinical use.
7. Type of Ground Truth Used
- Type of Ground Truth: Not explicitly stated. Given the description of the software's functions (e.g., identifying ablation targets, assessing probe placement, visualizing treatment zones post-ablation), the ground truth for features like probe identification and ROI/ablation zone segmentation would likely involve expert consensus on medical images (e.g., CT scans). However, the method for establishing this ground truth (e.g., expert consensus, pathology, outcome data) is not described.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not provided. This document is about verification and validation tests for substantial equivalence, not the development or training of an AI model.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not provided.
In summary, the provided 510(k) document is a regulatory submission focused on demonstrating substantial equivalence through a comparison to a predicate device and a high-level summary of verification and validation testing. It confirms that the device passed its "pre-determined acceptance criteria" but does not disclose the specific criteria or the detailed methodology and results of the studies that would typically address the specific points you requested (sample sizes, expert qualifications, ground truth methods, MRMC studies, etc.). This level of detail is usually found in a more comprehensive clinical or performance study report, which is not part of this 510(k) summary.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.